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FDA grants emergency use for Lilly’s COVID-19 antibody drug combination

Bamlanivimab plus etesevimab shown to reduce risk of death in high-risk COVID-19 patients

Eli Lilly’s monoclonal antibody combination treatment, bamlanivimab plus etesevimab, has gained an emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for COVID-19.

The EUA has been granted for bamlanivimab 700 mg and etesevimab 1400 mg, administered together, for the treatment of high-risk COVID-19 patients with mild-to-moderate disease.

The antibody combination is administered together via a single intravenous infusion, which should be given as soon as possible following a positive COVID-19 test and within ten days of symptom onset.

The FDA has authorised infusion times for both bamlanivimab alone and bamlanivimab plus etesevimab as 16 or 21 minutes, respectively.

Previously, the FDA had authorised an infusion time of 60 minutes for bamlanivimab alone when it approved the monoclonal antibody as a monotherapy in November 2020.

The EUA for the antibody combination is based on data from Lilly’s BLAZE-1 trial, which showed that bamlanivimab and etesevimab administered together significantly reduced the risk of hospitalisations and death in high-risk patients with mild-to-moderate COVID-19.

Across the study population, which included 1,035 patients, there were 11 COVID-related events in patients receiving Lilly’s antibody combination treatment, while 36 events occurred in the placebo group.

This represented a 70% risk reduction, with no deaths occurring in the bamlanivimab and etesevimab-treated group.

The antibody combination treatment also demonstrated significant improvements in all key secondary endpoints, with strong evidence that the therapy reduced viral load and accelerated symptom resolution, according to Lilly.

"Bamlanivimab alone under emergency use authorisation has already provided many people with an early treatment option that could prevent hospitalisations and we are excited to now add an additional therapeutic option with a similar demonstrated clinical benefit,” said Daniel Skovronsky, chief scientific officer of Lilly and president of Lilly Research Laboratories.

In December 2020, the US government purchased an additional 650,000 doses of bamlanivimab, increasing the total number of doses secured to 950,000.

The FDA also granted Regeneron’s antibody cocktail REGN-COV2 an EUA in November 2020, for the treatment of mild-to-moderate COVID-19 patients who are at high risk of progressing to severe disease and/or hospitalisation.

Regeneron’s EUA is based on data from the first 799 adults in an ongoing trial of the antibody cocktail in non-hospitalised COVID-19 outpatients.

In this study, REGN-COV2 met the primary endpoint in average daily change in viral load until day seven in patients with high viral load.

On a key clinical endpoint, REGN-COV2 treatment reduced COVID-19-related medical visits by 57% until day 29.

Treatment with REGN-COV2 also reduced COVID-19-related medical visits by 72% in patients with one or more risk factors.

Article by
Lucy Parsons

10th February 2021

From: Regulatory

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